The present invention generally relates to therapeutic procedures and devices used during radiation therapy. This device generally consists of a catheter with a therapeutic balloon positioned along at least a portion of its length. Radiotherapeutic members, tubes or elongated rods for containing radioactive material are engaged by and move with the therapeutic balloon when it is expanded. These rods or the like may be inserted in elongated pockets of the therapeutic balloon; they may also be secured to the balloon with loops attached to the inner or outer surfaces of the balloon, or they may be secured to a balloon surface with adhesive strips. The catheter and therapeutic balloon assembly is intended to be inserted into living body cavities through existing body orifices. Once the catheter and its therapeutic balloon are inserted in the prescribed manner into the body cavity, the balloon is inflated to move and hold the radioactive material into desired radiation treatment position within the body cavity during radiation therapy. The inflated therapeutic balloon also may be used to move, push, reposition, hold or otherwise manipulate body tissue during the radiation therapy.
This invention provides the physician with a new technique to treat cancers within the body. This invention is most useful to treat cancers inside or in the proximity of body cavities including the bladder, vagina, rectum, subglottic region, stomach, bronchial tubes, nasopharynx region, and the like. This invention permits radiation treatment within the human body without requiring interstitial insertion of radiotherapeutic rods or the like. Prior to this invention, application of radiotherapeutic rods typically required insertion of the rods through tissue. This invention provides an intracavitary alternative for radiating internal body tissues. Patient trauma and risk from infection, and other similar types of potential hazards of interstitial procedures are substantially reduced. Typically, this invention can lessen the training time and/or experience level required to perform internal radiation therapy where an interstitial procedure might ordinarily be employed in view of the elimination of more intensive procedures related to an interstitial insertion of the radiotherapeutic rods.
It is a general object of this invention to provide a significantly improved tool and procedure for radiation therapy in or near body cavities accessible through existing orifices.
Another object of the invention is to provide intracavitary radiation therapy at or nearer diseased tissues than possible with external radiation therapy.
Another object of the invention is to provide radiation therapy at or nearer diseased tissues without invasive or interstitial procedures and whether at a high dose rate during short treatment times of from 15 minutes to a few hours and up to 24 hours or at a low dose rate during longer treatment times of up to about 3 days or more.
Another object of the invention is to facilitate long-term, low dose rate radiation by enabling introduction of nutrients or air or evacuation of wastes through a therapeutic treatment device itself.
Another object of the invention is to utilize existing body cavities for radiation therapy in an intracavitary manner.
Another object of this invention is to provide a device and method suitable for use in the bladder by providing an elongated insertion catheter having drainage characteristics.
Another object of this invention is to permit the physician to tailor the size of a radiation treatment device to the particular therapeutic requirements of the body cavity being treated.
Another object of this invention is to maintain the position of a therapeutic device through the use of a smaller, secondary balloon located within a larger, therapeutic balloon.
Another object of this invention is to provide a device and method suitable for use in the rectum by providing a large diameter catheter having drainage characteristics.
Another object of this invention is to provide a device and method suitable for use in the vagina or rectum by providing a template which provides securement.
Another object of this invention is to provide a device and method suitable for use in the stomach by providing a catheter having inflow and outflow characteristics.
Another object of this invention is to provide a device and method suitable for use in the subglottic region by providing a catheter having inflow and outflow characteristics.
Another object of this invention is to provide a device and method suitable for use in the nasopharynx region by providing a catheter having inhalation and exhalation characteristics.
Another object of the invention is to provide a device and method that provide for inflow of nutrients and outflow of wastes to enable long-duration treatments.
These and other objects and advantages of the present invention will be apparent from the following description.